The study aims to compare the incidence of acute grade 2 GI toxicity in the Control 3-D Conformal Radiotherapy compared to the Intensity Modulated Radiotherapy (IMRT) arm for locally advanced rectal cancer.
Pre-operative radiotherapy (RT) or chemo-radiotherapy (CRT) is internationally accepted as standard practice in the management of locally advanced rectal cancer. Multiple randomised trials have proved pre-operative CRT and RT, compared to surgery alone, reduce local recurrence, even prior to optimal surgery, and may improve survival for T3 circumferential resection margin (CRM) negative patients. This study aims to determine if 3-DCRT or IMRT result in lower incidence of grade 2 GI toxicities. Acute toxicities will be assessed weekly during radiotherapy, and at 2 and 4 week post treatment. Late toxicities will be assessed at 3, 6, 9, 12, 18, 24 months post treatment, and annually to 10 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
IMRT will be given to some patients to enable comparison of the acute grade 2 GI toxicities compared to those patients receiving their radiotherapy by 3-DCRT
St Luke's Radiation Oncology Network at Beaumont Hospital
Dublin, Ireland
St Luke's Centre for Radiation Oncology at St James Hospital
Dublin, Ireland
St Luke's Centre for Radiation Oncology at St Lukes Hospital
Dublin, Ireland
Reduction in incidence of grade 2 or higher GI toxicity
To determine if there is a reduction in the incidence of grade 2 or higher acute GI toxicity in the IMRT arm, as compared to the Control / 3-D arm, graded by the NCI-CTCAE Version 4
Time frame: 10 years
Compare incidence of acute grade > 2 GU toxicity
To compare the incidence of acute grade \> 2 GU toxicity in the IMRT arm, as compared to the Control / 3-D arm, graded by the NCI-CTCAE Version 4
Time frame: 10 years
Evaluate incidence of late GI and GU toxicity
To evaluate the incidence of late GI and GU toxicity graded by the NCI-CTCAE Version 4
Time frame: 10 years
Rate of loco-regional control
To estimate the rate of loco-regional control by assessing CT / MRI imaging / biopsy
Time frame: 10 years
Assess quality of life
To assess QoL according to the EORTC QLQ-C30 and EORTC QLQ-CR29
Time frame: 10 years
Rate of disease free survival
To estimate the rate of disease-free survival
Time frame: 10 years
Estimate overall survival
To estimate the overall survival rate
Time frame: 10 years
Differences in the toxicity profile between the two types of neoadjuvant concomitant chemotherapy, graded by the NCI-CTCAE Version 4
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To compare the differences in the toxicity profile between the two types of neoadjuvant concomitant chemotherapy, graded by the NCI-CTCAE Version 4
Time frame: 10 years